Influence of Ultrasonographic Hydro-dissection With Glucose 5% on Nerve Block Efficiency (Hydro-Echo)

This study has been completed.
Sponsor:
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01058525
First received: January 27, 2010
Last updated: January 22, 2011
Last verified: January 2011
  Purpose

The real-time visualization of a needle and nerve during an ultrasound-guided nerve block can be challenging. These difficulties may partly explain the systemic complications of local anesthetics under ultrasound. Injection of small amounts of a solution around the anesthetized nerve (hydro-dissection) has been proposed to enhance contrast outlining its borders and also to improve the visualization of the needle tip. The glucose solution 5% solution is interesting because it allows, unlike saline, to maintain the motor response with neurostimulation. The hydro-dissection can be particularly useful when one suspect hypoechoic vessels near the nerve to be anesthetized. Thereby, the nerve well demarcated and separated from the vessels, injection of local anesthetic is performed in the circumferential diffusion space (like a small pocket) without redirecting needle.

The influence of this hydro-dissection on the nerve block efficiency is unknown. The nerve block quality can be improved because the entire anesthetic is injected in contact with the nerve, but it can also be reduced due to the dilution of the local anesthetic by the glucose solution.

In this randomized study, the investigators test the hypothesis that hydro-dissection does not alter the nerve block onset time.


Condition Intervention Phase
Nerve Block
Procedure: median nerve block
Procedure: median nerve block after hydro-dissection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Ultrasonographic Hydro-dissection With Glucose 5% Solution on Median Nerve Block Efficiency: a Prospective and Randomized Study

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Onset time of sensory blockade (light touch test: total loss of sensation at the two distal phalanges of index) [ Time Frame: 30 minutes after injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Onset time of sensory blockade (cold test at index finger and thenar eminence) [ Time Frame: 30 minutes after injection ] [ Designated as safety issue: No ]
  • Onset time (light touch test at thenar eminence) [ Time Frame: 30 minutes after injection ] [ Designated as safety issue: No ]
  • Onset time for motor blockade [ Time Frame: 30 minutes after injection ] [ Designated as safety issue: No ]
  • Success rate (% of patients with total light touch block at index finger within 30 min evaluation period) [ Time Frame: 30 minutes after injection ] [ Designated as safety issue: No ]
  • Successful surgical anesthesia [ Time Frame: 30 minutes after injection ] [ Designated as safety issue: No ]
  • Duration of nerve blockade [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Nerve block complication [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Duration of the puncture procedure [ Time Frame: 30 minutes after the beginning of the procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: nerve block
median nerve block (6 ml lidocaine 1.5 % with adrenalin 1:200000)
Procedure: median nerve block
median nerve block performed using ultrasound guidance
Experimental: median nerve block after hydro-dissection
median nerve block (6 ml lidocaine 1.5 % with adrenalin 1:200000) after hydro-dissection (glucose 5% solution)
Procedure: median nerve block after hydro-dissection
median nerve block performed after hydro-dissection (glucose 5% solution), both using ultrasound guidance

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with an ASA physical status I-II scheduled for elective ambulatory surgery of the hand or wrist involving the median nerve

Exclusion Criteria:

  • Patients with type 1 or 2 diabetes mellitus,
  • History of clinical or laboratory evidence of abnormal bleeding,
  • Infection at the injection site,
  • Allergy to local anesthetic,
  • Preexisting central or peripheral muscular or neurological disease (for example: carpal tunnel syndrome)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058525

Locations
France
Hôpital Privé de l'Ouest Parisien
Trappes, France, 78190
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler Hôpital Foch
  More Information

No publications provided by Hopital Foch

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marc Fischler, Professor, Hôpital Foch
ClinicalTrials.gov Identifier: NCT01058525     History of Changes
Other Study ID Numbers: 2009/27
Study First Received: January 27, 2010
Last Updated: January 22, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on September 30, 2014